LAB EQUIPMENT VALIDATION SME

Position Description.
The Lab Equipment Validation SME will specifically be a member of the CGI Life Science Industry Practice and will be preparing manufacturing and research sites for converting processes, analyses, and master data to new equipment and systems.
Your future duties and responsibilities.
• Provides subject-matter expertise and support to medical science instrumentation and lab systems equipment as needed.
This would include the complete array of lab systems equipment, Spectrometer, Chromatography, Sensors, Scanners, Meters, Stirrers etc.
• Develop close working relationships with all various quality and labs teams from management downstream to hyper care support teams • Manage and lead all site validation activities along with the calibration and validation of test and data analysis equipment and systems used for equipment validation, change controls, and remediation.
• Lab Software and Manufacturing Execution System Expertise and Familiarity required; Mettler Toledo Systems, shop floor instrumentation, quality labs optimization, labs stand-ups, infrastructure, integrations, validation, procedures and training • Translate business process & technical alignment (including gap-analysis) requirements into qualification/validation test design documents and plans • Familiar with software deployment and development life cycles.
Possess excellent customer consulting, written and communication skills.
• Understand and make recommendation to the system processes, environments, SOPs, training and procedures • Document system and use processes and business continuity procedures for Customer review and approval • Provisioning users on systems undergoing validation and document steps • Track down root cause of errors during qualification and testing of systems undergoing validation activities and document solutions • Assist with system configuration and changes as directed by Client Lead and document results/procedure to configure • Demonstrates facility in client-facing activities including.
• Eliciting and documenting business requirements.
• Analyzing and validating business requirements.
• Translating business requirements into system and non-functional requirements.
• Facilitating requirements review sessions with business and IT.
• Assists business clients with developing new business processes or modifying existing business processes (during implementation, may help develop communication material; define supporting procedures and standards; document training materials; assist in the immediate training effort; etc.).
• Assists in the creation of business cases and other related financial planning, impact identification, or value justification.
• Adheres to Solution Delivery Lifecycle (SDLC) and Agile Scrum New Ways of Working principles • Develops the right skills to meet the future needs of the organization.
Required qualifications to be successful in this role.
• Lab Software and Manufacturing Execution System Expertise and Familiarity required.
shop floor instrumentation, quality labs optimization, labs stand-ups, infrastructure, integrations, validation, procedures and training • Working Knowledge of Agile Scrum New Ways of Working & SDLC • GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience.
• Skill in conceptualizing creative solutions, as well as documenting them and presenting/selling them to senior management.
Confident and positive attitude, able to liaise with stakeholders at all levels and navigate company culture • Strong knowledge and understanding of business needs, with the ability to establish and maintain a high level of customer trust and confidence • Ability to support internal and external projects from inception to successful implementation • Familiarity with software development process, including requirement gathering, analysis/design, development tools/technologies, release/version control, contemporary testing methodologies and deployment management • Exceptional verbal and written communication skills; expertise in setting and managing customer expectations • Strong customer focus and ability to manage Client expectations • Excellent communication and interpersonal skills.
• Strong organizational skills, able to make good decisions in a collaborative manner • Bachelor’s degree in fields associated to labs and quality control systems #LI-CG1 CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role.
The determination of this range includes various factors not limited to.
skill set level; experience and training; and licensure and certifications.
CGI typically does not hire individuals at or near the top of the range for their role.
Compensation decisions are dependent on the facts and circumstances of each case.
A reasonable estimate of the current range is $.
We offer a competitive compensation package where you’ll be rewarded based on your performance and recognized for the value you bring to our business.
In addition, our benefits package includes multiple medical, dental, & vision options, both a Shared Purchase Plan (SPP) for CGI stocks and a 401(k) plan, as well as numerous other lifestyle benefits.
CGI also provides sick leave and vacation pay.
Skills.
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are contingent upon the ability to successfully complete a background investigation.
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